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Nystatin Pessaries 100 000 Units

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Document: leaflet MAH BRAND_PL 33414-0071 change

PATIENT INFORMATION LEAFLET

NYSPES

Nystatin Pessaries 100,000 Units

PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE

What is in your medicine?

The name of this medicine is NYSPES and each pessary contains Nystatin in a strength of 100,000 Units.

NYSPES pessaries contain: Lactose, maize starch, sodium starch glycollate, povidone and magnesium stearate.

NYSPES are available in containers of 100 and 500 pessaries. How do NYSPES work?

NYSPES contain Nystatin, an antifungal antibiotic which is active against candida albicans and a wide range of yeasts and yeast-like fungi.

If you are not sure why you have been prescribed NYSPES, then please ask your doctor.

The Manufacturer of NYSPES is: DDSA Pharmaceuticals Ltd., Chatfield Road, off York Road, London SW11 3SE.

The Product Licence holder is: Chelonia Healthcare Limited, Boumpoulinas 11, 3rd Floor, Nicosia, P.C. 1060, CYPRUS.

What are NYSPES for?

NYSPES are used for the treatment Candidal vaginitis.

Check before you take NYSPES Pessaries

Before taking this medicine, tell your doctor if you have ever had any unusual or allergic reactions to Nystatin or any of the other ingredients of NYSPES, or other antibiotic medicines.

Use in pregnancy

In pregnancy care should be taken when using the applicator supplied for inserting the pessary, to prevent the possibility of injury to the uterus.

Children: Not recommended for use in children.

What to do if too many pessaries are taken at the same time

If you accidentally use more pessaries at the same time than recommended, contact your doctor or hospital out-patients department.

What to do if you miss a dose

If you miss a dose, skip the missed dose and go back to your regular dosage schedule. Do not double the dose.

What side effects can NYSPES have?

There are no known side-effects to NYSPES, except the possibility of hypersensitivity to Nystatin or to any of the ingredients listed. If you experience an allergic reaction or any other undesirable effects you should contact your doctor.

Storing your medicine

You must keep the medicine in a safe place where children cannot get it. Your medicine could harm them.

Store below 25°C. and protect from light. Keep the pessaries in the container in which they were given to you, and keep it tightly closed.

On the label you will find the words "Expiry Date" followed by numbers indicating the day, month and year. This is the date when the medicine is no longer fit for use. Do not use NYSPES after this date.

A reminder

REMEMBER this medicine is for you. Never give it to someone else, even if their symptoms are the same as yours.

This leaflet does not contain the complete information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist who have access to additional information.

PL 33414/0071

This leaflet was last approved in November 2008.

When and how to take NYSPES

NYSPES should be taken by inserting the pessaries into the vagina, using the applicator provided.

Dosage:

Adults, including the elderly: 1 or 2 pessaries should be inserted high into the vagina for 14 consecutive nights, or longer, regardless of whether you have your period or not.